ACRYSOF® SN6AT4 (REF SN6AT4.230)Recalls & reported problems
Alcon Laboratories, Inc. · AcrySof(R) IQ TORIC ASTIGMATISM IOL, SINGLE-PIECE ACRYLIC FOLDABLE LENS, UV WITH BLUE LIGHTFILTER, 13.0mm LENGTH, 6.0mm BICONVEX TORICASPHERIC OPTIC, 2.25 D CYLINDER. · Class 3 · Implant
All models of ACRYSOF (353)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 5
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00380652250481), received between Feb 2, 2022 and Sep 12, 2025 — classified as 1 injury, 4 malfunctions.
The most frequently reported specific device problem is “Device Contamination with Chemical or Other Material” (3 reports).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Reports received per month
Most reported problems
Device problems
- Device Contamination with Chemical or Other Material3
- Break1
- Scratched Material1
Patient problems
- Insufficient Information3
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 12, 2025Break; Break
THE EVENT REPORT FOR THIS FILE WAS RECEIVED FROM THE CHINESE HEALTH AUTHORITY. A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE OPERATOR FOUND THAT THE HAPTICS WAS BROKEN, SO IT WAS STOPPED AND REPLACED WITHOUT ANY ADVERSE EFFECTS ON THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23036613 ↗MalfunctionMar 27, 2023Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
A PHARMACY EMPLOYEE REPORTED DURING THE INTRAOCULAR LENS IMPLANTATION THERE WAS BLACK DUST ON THE IMPLANT AND HENCE FAILURE PLACEMENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 16620748 ↗MalfunctionAug 11, 2022Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
A PHYSICIAN REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, SOME HARD DRIED MATERIAL AT THE POSTERIOR SURFACE OF THE INTRAOCULAR LENS. THE FOREIGN MATERIAL WAS ASPIRATED AWAY BUT LEAVING MINIMAL RESIDUE ON THE INTRAOCULAR LENS. NO MORE INFORMATION AVAILABLE.
Patient problems: Insufficient Information
MAUDE report 15210831 ↗MalfunctionApr 29, 2022Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
A NON-HEALTH CARE PROFESSIONAL REPORTED DURING THE INTRAOCULAR LENS IMPLANTATION DEBRIS WAS NOTED ON THE INTRAOCULAR LENS AFTER IT WAS IMPLANTED INTO THE EYE. THE LENS WAS REMOVED AND REPLACED WITH A BACK UP LENS OF THE SAME MODEL AND DIOPTER. NO VITRECTOMY, SUTURE OF LENS OR INCISION OR INCISION ENLARGEMENT WAS NEEDED. CAPSULE BAG WAS INTACT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 14250879 ↗InjuryFeb 2, 2022Scratched Material; Scratched Material
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, SPOT ON LENS WAS IDENTIFIED. THE IOL WAS EXCHANGED IN A SECONDARY PROCEDURE WITH AN ALTERNATE IOL. NO FURTHER INFORMATION IS EXPECTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13422555 ↗
Other intraocular lens devices
- TECNIS IOL PCB00Johnson & Johnson Surgical Vision, Inc. · intraocular lens146 reports
- TECNIS IOL PCB00Johnson & Johnson Surgical Vision, Inc. · intraocular lens145 reports
- TECNIS IOL PCB00Johnson & Johnson Surgical Vision, Inc. · intraocular lens144 reports
- TECNIS IOL PCB00Johnson & Johnson Surgical Vision, Inc. · intraocular lens139 reports
- TECNIS SIMPLICITY DIB00Johnson & Johnson Surgical Vision, Inc. · intraocular lens1 recall81 reports
- TECNIS IOL PCB00Johnson & Johnson Surgical Vision, Inc. · intraocular lens129 reports
- TECNIS IOL PCB00Johnson & Johnson Surgical Vision, Inc. · intraocular lens127 reports
- TECNIS IOL PCB00Johnson & Johnson Surgical Vision, Inc. · intraocular lens126 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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